JPRN-jRCT2080221343未知3 期
Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 228
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Subjects who are diagnosed as ulcerative colitis
- •2)Subjects who are total score of 4-10 on the Ulcerative Colitis Disease Activity Index (UC-DAI) with a sigmoidoscopy score of 1 or higher, a rectal bleeding score of 1 or higher and a Physician's Global Assessment (PGA) score of 2 or less at the baseline
- •3)Outpatients
排除标准
- •1)Subjects who are classified to severe ulcerative colitis by severity classification
- •2)Subjects with a history of colectomy (except appendectomy)
- •3)Subjects with moderate/severe renal or liver impairment
- •4)Subjects with serious blood disorder, respiratory disorder, digestive disorder, cardiovascular disorder, psychiatric disorder, abnormal electrolyte metabolism disorder or hypersensitivity as complication
- •5)Subjects with malignant tumor as complication
研究者
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